Maternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain
Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública, CIBERESP, Madrid, Spain.
BMJ Open. 2021 Nov 23;11(11):e053197. doi: 10.1136/bmjopen-2021-053197.
Malaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine is recommended for malaria prevention in HIV-uninfected women, but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. Dihydroartemisinin-piperaquine (DHA-PPQ) has been shown to improve antimalarial protection, constituting a promising IPTp candidate. This trial's objective is to determine if monthly 3-day IPTp courses of DHA-PPQ added to daily CTXp are safe and superior to CTXp alone in decreasing the proportion of peripheral malaria parasitaemia at the end of pregnancy.
This is a multicentre, two-arm, placebo-controlled, individually randomised trial in HIV-infected pregnant women receiving CTXp and antiretroviral treatment. A total of 664 women will be enrolled at the first antenatal care clinic visit in sites from Gabon and Mozambique. Participants will receive an insecticide-treated net, and they will be administered monthly IPTp with DHA-PPQ or placebo (1:1 ratio) as directly observed therapy from the second trimester of pregnancy. Primary study outcome is the prevalence of maternal parasitaemia at delivery. Secondary outcomes include prevalence of malaria-related maternal and infant outcomes and proportion of adverse perinatal outcomes. Participants will be followed until 6 weeks after the end of pregnancy and their infants until 1 year of age to also evaluate the impact of DHA-PPQ on mother-to-child transmission of HIV. The analysis will be done in the intention to treat and according to protocol cohorts, adjusted by gravidity, country, seasonality and other variables associated with malaria.
The protocol was reviewed and approved by the institutional and national ethics committees of Gabon and Mozambique and the Hospital Clinic of Barcelona. Project results will be presented to all stakeholders and published in open-access journals.
NCT03671109.
妊娠期间疟疾感染是孕产妇和新生儿健康的一个重要驱动因素，尤其是在感染艾滋病毒的妇女中。磺胺多辛-乙胺嘧啶间歇性预防治疗（IPTp）推荐用于预防未感染艾滋病毒的妇女的疟疾，但由于潜在的不良反应，在接受复方磺胺甲噁唑预防（CTXp）的感染艾滋病毒的妇女中是禁忌的。二氢青蒿素-哌喹（DHA-PPQ）已被证明能提高抗疟保护作用，是一种有前途的 IPTp 候选药物。本试验的目的是确定每月 3 天的 DHA-PPQ IPTp 疗程与单独使用 CTXp 相比，是否能更安全地降低妊娠结束时外周疟疾寄生虫血症的比例。
这是一项在接受 CTXp 和抗逆转录病毒治疗的感染艾滋病毒的孕妇中进行的多中心、双臂、安慰剂对照、个体随机试验。总共将在加蓬和莫桑比克的多个地点招募 664 名在第一次产前保健诊所就诊的孕妇。参与者将接受驱虫蚊帐，并从妊娠中期开始接受每月 DHA-PPQ 或安慰剂（1:1 比例）的 IPTp 治疗，作为直接观察治疗。主要研究结果是分娩时产妇寄生虫血症的患病率。次要结果包括疟疾相关的孕产妇和婴儿结局的患病率以及不良围产期结局的比例。参与者将被随访至妊娠结束后 6 周，其婴儿将被随访至 1 岁，以评估 DHA-PPQ 对母婴 HIV 传播的影响。分析将按意向治疗和方案队列进行，调整因素包括妊娠次数、国家、季节性和其他与疟疾相关的变量。
该方案已经经过加蓬和莫桑比克的机构和国家伦理委员会以及巴塞罗那医院诊所的审查和批准。项目结果将呈现给所有利益相关者，并发表在开放获取期刊上。
NCT03671109。
